DUODERM PASTE AND GELS
Received Feb 13, 2026
Report 1000317571-2026-00021 · MDR key 24334287
Device
Generic name
Dressing, Wound, Hydrogel Without Drug And/or Biologic
Manufacturer
Convatec LtdModel number
187987Lot number
4H03647
Product problems
- Gel Leak
- Delivered as Unsterile Product
Patient
NA · Unknown
- No Clinical Signs, Symptoms or Conditions
Narrative
Description of Event or Problem
IT WAS REPORTED BY THE DISTRIBUTOR THAT THERE HAD BEEN LEAKAGE IN THE GEL TUBE DESPITE THE PRODUCT BEING SEALED. THE PRODUCT WAS NOT USED, AND NO PHOTOGRAPH WAS AVAILABLE AT THE TIME OF THE REPORT.
Additional Manufacturer Narrative
E1: COMPLAINANT STREET ADDRESS: (B)(6) COMPLAINANT COUNTRY: TAIWAN, PROVINCE OF CHINA. BASED ON THE AVAILABLE INFORMATION, THIS EVENT IS DEEMED TO BE A REPORTABLE MALFUNCTION. TO DATE NO ADDITIONAL INFORMATION HAS BEEN RECEIVED. SHOULD ADDITIONAL INFORMATION BECOME AVAILABLE, A FOLLOW-UP REPORT WILL BE SUBMITTED. FDA REGISTRATION NUMBER REPORTING SITE: 1049092 MANUFACTURING SITE:1000317571.